BACKGROUND: Ehlers-Danlos syndrome (EDS) and its connective tissue laxity often result in high-grade lumbosacral spondylolisthesis. Patients present with debilitating symptoms and neurological deficits. Reports of surgical techniques in non-EDS patients for the treatment of high-grade lumbosacral spondylolisthesis mainly described an open approach, multilevel fusions, and multiple stages with different circumferential approaches. Sagittal adjusting screws (SASs) can be used in a minimally invasive (MI) fashion, allowing intraoperative reduction.
METHODS: A 17-year-old female with EDS presented to the authors\' institute with severe lower back and left L5 radicular pain in 2017. She presented with a left foot drop and difficulty ambulating. Magnetic resonance imaging showed grade IV L5-S1 spondylolisthesis. She underwent lumbar fusion for intractable back pain with radiculopathy. Intraoperatively, percutaneous SASs and extension towers were used to distract the L5-S1 disc space and reduce the spondylolisthesis. MI transforaminal lumbar interbody fusion was completed with significant symptomatic relief postoperatively. The patient was discharged to home 3 days postoperatively. Routine follow-up visits up to 3 years later demonstrated solid fusion radiographically and favorable patient-reported outcomes.
CONCLUSIONS: The authors used SASs in a MI approach to successfully correct and stabilize grade IV spondylolisthesis in an EDS patient with a favorable long-term patient-reported outcome.

OBJECTIVE The purpose of this study was to investigate whether the intraoperative application of an epidural steroid (ES) on the decompressed nerve root improves short- and midterm subjective and objective clinical outcomes after lumbar microdiscectomy. METHODS This study was a retrospective analysis of a 2-center database including consecutive cases in which patients underwent lumbar microdiscectomy. All patients who received ES application (40 mg triamcinolone, ES group) were matched by age and sex to patients who had not received ES application (control group). Objective functional impairment (OFI) was determined using age- and sex-adjusted T-scores of the Timed Up and Go (TUG) test. Back and leg pain (visual analog scale), functional impairment (Oswestry Disability Index [ODI], Roland-Morris Disability Index [RMDI], and health-related quality of life (hrQoL; 12-Item Short Form Health Survey [SF-12] physical component summary [PSC] score and EuroQol [EQ-5D index]) were measured at baseline, on postoperative day 3, and at postoperative week 6. RESULTS Fifty-three patients who received ES application were matched with 101 controls. There were no baseline demographic or disease-specific differences between the study groups, and preoperative pain, functional impairment, and hrQoL were similar. On postoperative day 3, the ES group had less disability on the RMDI (mean 7.4 vs 10.3, p = 0.003) and higher hrQoL as determined by the SF-12 PCS (36.5 vs 32.7, p = 0.004). At week 6, the ES group had less disability on the RMDI (3.6 vs 5.7, p = 0.050) and on the ODI by trend (17.0 vs 24.4, p = 0.056); better hrQoL, determined by the SF-12 PCS (44.3 vs 39.9, p = 0.018); and lower OFI (TUG test T-score 100.5 vs 110.2, p = 0.005). The week 6 responder status based on the minimum clinically important difference (MCID) was similar in the ES and control groups for each metric. The rates and severity of complications were similar, with a 3.8% and 4.0% reoperation rate in the ES group and control group, respectively (p = 0.272). There was a tendency for shorter hospitalization in the ES group (5.0 vs 5.8 days, p = 0.066). CONCLUSIONS Intraoperative ES application on the decompressed nerve root is an effective adjunct treatment that may lower subjective and objective functional impairment and increase hrQoL in the short and intermediate term after lumbar microdiscectomy. However, group differences were lower than the commonly accepted MCIDs for each metric, indicating that the effect size of the benefit is limited. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: retrospective cohort trial; evidence: Class II.

OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ).

OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.

OBJECT A lack of information exists on the relationship between preoperative epidural spinal injections and outcomes after spine surgery. There is concern that injections might cause local changes, increasing the infection risk and surgical difficulty. Therefore, the authors explored the relationship between preoperative spinal injections and postoperative outcome. METHODS The cohort was comprised of patients who underwent thoracic and/or lumbar arthrodesis during the years 2007-2010 and had complete (preoperatively and 3 months postoperatively) outcome scores. Patients\' clinical courses were reviewed to determine the occurrence of major complications within a 30-day postoperative period. Patient-perceived outcomes were evaluated using the Oswestry Disability Index (ODI) and the SF-12 (12-Item Short Form Health Survey): mental component summary (MCS) and physical component summary (PCS) scores. Analyses were based on exposure to injections and were performed using chi-square exact tests and paired and unpaired t-tests. RESULTS Two hundred eighty patients met the inclusion criteria: 117 patients (41.8%) received and 163 patients (58.2%) did not receive preoperative epidural spinal injections. Overall, the likelihood of complication did not differ with respect to exposure (13.7% injection vs 11.7% noninjection); however, injected patients observed a 7.4-fold risk of developing surgical wound complications over noninjected patients (5.1% vs 0.6%, p = 0.02). Patient-perceived outcomes measures demonstrated no differences between groups. Three months postoperatively, the MCS and ODI scores were similar (MCS: 49.6 ± 11.6 injection vs 47.4 ± 12.8 noninjection; ODI: 35.8 ± 18.0 vs 34.4 ± 19.1). MCS or ODI score improvement (preoperatively compared with 3 months postoperatively) did not vary between groups. Injected patients maintained a 2-point lower PCS score at entry and 3 months postoperatively as compared with noninjected peers (entry: 27.6 ± 8.2 injection vs 29.5 ± 9.3 noninjection, p = 0.09; 3 months: 33.3 ± 8.6 vs 35.7 ± 9.0, p = 0.03); the PCS score improvements between injected and noninjected groups were similar (5.7 ± 9.9 vs 6.2 ± 9.7). CONCLUSIONS Patients exposed to preoperative epidural injections had similar complication rates to those who never received a spinal injection. However, they had a greater risk of developing wound complications. These complications had no effect on short-term improvements in outcome measures.

OBJECTIVE: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months\' follow-up.
METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.
RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.
CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

OBJECTIVE: Despite limited availability and the morbidity associated with autologous iliac crest bone graft (ICBG), its use in anterior lumbar interbody fusion (ALIF) procedures remains the gold standard to achieve arthrodesis. The search for alternative grafts yielding comparable or superior fusion outcomes with fewer complications continues. In particular, i-FACTOR, a novel bone graft substitute composed of anorganic bone matrix (ABM) with P-15 small peptide, is one example currently used widely in the dental community. Although preclinical studies have documented its usefulness, the role of i-FACTOR in ALIF procedures remains unknown. The authors\' goal was to determine the safety and efficacy of i-FACTOR bone graft composite used in patients who underwent ALIF by evaluating fusion rates and clinical outcomes.
METHODS: A nonblinded cohort of patients who were all referred to a single surgeon\'s practice was prospectively studied. One hundred ten patients with degenerative spinal disease underwent single or multilevel ALIF using the ABM/P-15 bone graft composite with a mean of 24 months (minimum 15 months) of follow-up were enrolled in the study. Patient\'s clinical outcomes were assessed using the Oswestry Disability Index for low-back pain, the 12-Item Short Form Health Survey, Odom\'s criteria, and a visual analog scale for pain. Fine-cut CT scans were used to evaluate the progression to fusion.
RESULTS: All patients who received i-FACTOR demonstrated radiographic evidence of bony induction and early incorporation of bone graft. At a mean of 24 months of follow-up (range 15-43 months), 97.5%, 81%, and 100% of patients, respectively, who had undergone single-, double-, and triple-level surgery exhibited fusion at all treated levels. The clinical outcomes demonstrated a statistically significant (p < 0.05) difference between preoperative and postoperative Oswestry Disability Index, 12-Item Short Form Health Survey, and visual analog scores.
CONCLUSIONS: The use of i-FACTOR bone graft substitute demonstrates promising results for facilitating successful fusion and improving clinical outcomes in patients who undergo ALIF surgery for degenerative spinal pathologies.

The utilization of orthotic devices for lumbar degenerative disease has been justified from both a prognostic and therapeutic perspective. As a prognostic tool, bracing is applied prior to surgery to determine if immobilization of the spine leads to symptomatic relief and thus justify the performance of a fusion. Since bracing does not eliminate motion, the validity of this assumption is questionable. Only one low-level study has investigated the predictive value of bracing prior to surgery. No correlation between response to bracing and fusion outcome was observed; therefore a trial of preoperative bracing is not recommended. Based on low-level evidence, the use of bracing is not recommended for the prevention of low-back pain in a general working population, since the incidence of low-back pain and impact on productivity were not reduced. However, in laborers with a history of back pain, a positive impact on lost workdays was observed when bracing was applied. Bracing is recommended as an option for treatment of subacute low-back pain, as several higher-level studies have demonstrated an improvement in pain scores and function. The use of bracing following instrumented posterolateral fusion, however, is not recommended, since equivalent outcomes have been demonstrated with or without the application of a brace.

Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient\'s pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome.